Recruiting

Liquid Biopsies & Tumor Profiling

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05049538

Conditions

Endometrial Clear Cell Adenocarcinoma

Endometrial Dedifferentiated Carcinoma

Endometrial Mucinous Adenocarcinoma

Endometrial Serous Adenocarcinoma

Malignant Uterine Neoplasm

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Liquid Biopsy

Pap Smear

Study Details

Brief summary:

This study is to find out how well liquid biopsies work as a non-invasive alternative to other methods of finding cancer cells (such as a tissue biopsy) in patients with endometrial cancer. A liquid biopsy is a blood test that may be able to find cancer cells. Collecting and storing samples of blood and tissue from patients with endometrial cancer to study in the laboratory may help doctors learn how the cells in the blood may change during treatment for uterine cancer.

Conditions

Endometrial Clear Cell Adenocarcinoma

Endometrial Dedifferentiated Carcinoma

Endometrial Mucinous Adenocarcinoma

Endometrial Serous Adenocarcinoma

Malignant Uterine Neoplasm

Study ID

NCT05049538

Start date

Jun 18, 2019

Status verified date

Apr, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women age 18 years and older
  • Histologic diagnosis of endometrial cancer
  • Candidate for primary surgical treatment or has recently had prior primary surgery
  • Willing and able to provide informed consent

Exclusion Criteria:

Patients who have received prior treatment including chemotherapy or radiation therapy for endometrial cancer. Prior hormonal therapy for the treatment of endometrial cancer is allowed. Patients with prior primary surgery will be allowed to enroll in this trial if the patient has not received any chemotherapy or radiation at the time of enrollment. Note: patients with a history of other cancers may be enrolled after discussion with the PI if it is determined that they are at low risk for recurrence or metastasis.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (biospecimen collection, Pap smear)

Patients undergo collection of blood samples for liquid biopsy during pre-treatment consultation before hysterectomy, after hysterectomy but before starting any chemotherapy, and at the end of last chemotherapy cycle. Patients also undergo collection of tissue samples during hysterectomy. Patients may also undergo Pap smears before and after hysterectomy.

Interventions

Biospecimen Collection

Undergo collection of blood and tissue samples

Liquid Biopsy

Undergo liquid biopsy

Pap Smear

Undergo Pap smear

Primary outcome measure

  • Proportion of circulating cell free deoxyribonucleic acid (ccfDNA) mutations [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Pamela T Soliman, MD

713-745-2352psoliman@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Pamela T. Soliman

713-745-2352psoliman@mdanderson.org

Principal Investigator:

Pamela T. Soliman

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-06.